Covid19NCT04527458
Case Fatalities in Hospitalised COVID-19 Patients in the UK
An observational study of Covid19, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
This study will investigate how the case fatality in hospitalised patients with COVID-19 has changed throughout the pandemic. It will also explore possible mechanisms that could be driving these changes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19
- What is being tested?
- Patient Characteristics, COVID-19 treatments and Differences in triage
- How many people
- 70,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Feb 2020to 2 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with proven or high likelihood of COVID-19 admitted to the 260 UK hospitals enrolled in the ISARIC-4C study
Who may be able to join
- All patients admitted with a proven or high likelihood of COVID-19
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Case Fatalities in Hospitalised COVID-19 Patients in the UK: An ISARIC Study
This study will investigate how the case fatality in hospitalised patients with COVID-19 has changed throughout the pandemic. It will also explore possible mechanisms that could be driving these changes. This analysis will enhance our understanding of the virus, which will be important for researchers and clinicians to respond appropriately.
- Conditions
- Covid19
- Being tested
- Patient Characteristics, COVID-19 treatments, Differences in triage, Surge capacity
- Keywords
- COVID-19, ISARIC, Hospitalisations, Mortality, Case fatality, United Kingdom
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient CharacteristicsOther
Characteristics of the patients
COVID-19 treatmentsOther
Specific treatments used on COVID-19 patients
Differences in triageOther
Triage criteria for treating COVID-19 patients
Surge capacityOther
Capacity of hospitals
| Study group | Role | What they receive |
|---|---|---|
| Hospitalisations | All hospitalised COVID patients Receives: Other: Patient Characteristics; Other: COVID-19 treatments; Other: Differences in triage; Other: Surge capacity | |
| Critical care | All hospitalised COVID patients in critical care Receives: Other: Patient Characteristics; Other: COVID-19 treatments; Other: Differences in triage; Other: Surge capacity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Case fatality
The proportion of new admissions with COVID-19 who died over time
Measured: 23 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start24 Feb 2020
- Primary completion2 Aug 2020
- Study completion2 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- International Severe Acute Respiratory and Emerging Infection Consortium, BREATHE Health Data Research Hub
- Responsible party
- Sponsor
- Investigators
- Annemarie B Docherty, Principal investigator, Usher Institute, University of EdinburghEwen M Harrison, Principal investigator, Usher Institute, University of EdinburghRachel H Mulholland, Principal investigator, Usher Institute, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527458
- Sponsor's protocol ID
- ISARIC_COVID_CF
- Status last verified
- Aug 2020
- First submitted
- 24 Aug 2020
- Last updated
- 26 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to all data and samples collected by ISARIC4C are controlled by an Independent Data and Materials Access Committee (IDAMAC), composed of representatives of research funders, academia, clinical medicine, public health and industry. Their job is to ensure that all data and samples are used to generate the greatest possible benefit to humanity, in the shortest possible time.
Publications
Docherty AB, Harrison EM, Green CA, Hardwick HE, Pius R, Norman L, Holden KA, Read JM, Dondelinger F, Carson G, Merson L, Lee J, Plotkin D, Sigfrid L, Halpin S, Jackson C, Gamble C, Horby PW, Nguyen-Van-Tam JS, Ho A, Russell CD, Dunning J, Openshaw PJ, Baillie JK, Semple MG; ISARIC4C investigators. Features of 20 133 UK patients in hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: prospective observational cohort study. BMJ. 2020 May 22;369:m1985. doi: 10.1136/bmj.m1985.
PubMed 32444460
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case Fatalities in Hospitalised COVID-19 Patients in the UK: An ISARIC Study
- ClinicalTrials.gov ID
- NCT04527458
- Acronym / sponsor ID
- ISARIC_COVID_CF
- Conditions
- Covid19
- Keywords
- COVID-19, ISARIC, Hospitalisations, Mortality, Case fatality, United Kingdom
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70,000 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- International Severe Acute Respiratory and Emerging Infection Consortium, BREATHE Health Data Research Hub
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 2 Aug 2020 (actual)
- Study completion
- 2 Aug 2020 (actual)
- First posted
- 26 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate how the case fatality in hospitalised patients with COVID-19 has changed throughout the pandemic. It will also explore possible mechanisms that could be driving these changes. This analysis will enhance our understanding of the virus, which will be important for researchers and clinicians to respond appropriately.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospitalisations | – | Other: Patient Characteristics, Other: COVID-19 treatments, Other: Differences in triage, Other: Surge capacityAll hospitalised COVID patients |
| Critical care | – | Other: Patient Characteristics, Other: COVID-19 treatments, Other: Differences in triage, Other: Surge capacityAll hospitalised COVID patients in critical care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with proven or high likelihood of COVID-19 admitted to the 260 UK hospitals enrolled in the ISARIC-4C study
Key inclusion criteria (1 listed)
- All patients admitted with a proven or high likelihood of COVID-19
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient CharacteristicsCharacteristics of the patients | Other | Critical care, Hospitalisations |
| COVID-19 treatmentsSpecific treatments used on COVID-19 patients | Other | Critical care, Hospitalisations |
| Differences in triageTriage criteria for treating COVID-19 patients | Other | Critical care, Hospitalisations |
| Surge capacityCapacity of hospitals | Other | Critical care, Hospitalisations |
Primary outcome
Case fatality
Time frame: 23 weeks
The proportion of new admissions with COVID-19 who died over time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
- Background: PubMed 32444460Docherty AB, Harrison EM, Green CA, Hardwick HE, Pius R, Norman L, Holden KA, Read JM, Dondelinger F, Carson G, Merson L, Lee J, Plotkin D, Sigfrid L, Halpin S, Jackson C, Gamble C, Horby PW, Nguyen-Van-Tam JS, Ho A, Russell CD, Dunning J, Openshaw PJ, Baillie JK, Semple MG; ISARIC4C investigators. Features of 20 133 UK patients in hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: prospective observational cohort study. BMJ. 2020 May 22;369:m1985. doi: 10.1136/bmj.m1985.
- ISARIC 4C websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Access to all data and samples collected by ISARIC4C are controlled by an Independent Data and Materials Access Committee (IDAMAC), composed of representatives of research funders, academia, clinical medicine, public health and industry. Their job is to ensure that all data and samples are used to generate the greatest possible benefit to humanity, in the shortest possible time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annemarie B Docherty principal investigator
Usher Institute, University of Edinburgh
Ewen M Harrison principal investigator
Usher Institute, University of Edinburgh
Rachel H Mulholland principal investigator
Usher Institute, University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Case fatality (time frame: 23 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04527458, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2020.